Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Traumatic Brain Injury
- Sponsor
- Northwestern University
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Change in the Mayo Portland Adaptability Inventory (MPAI)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.
Investigators
Theresa Pape
Research Health Scientist
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age and no older than 80 years of age
- •3 months post exposure to mTBI event
- •Have a history of mTBI with PTSD OR mTBI without PTSD as defined by formalized measures to classify mTBI based on the Symptom Attribution and Classification Algorithm (SACA) and the PTSD Module L of the SCID
- •Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory
Exclusion Criteria
- •Participating in another research study
- •Non-fluent in English (speaking and reading)
- •History of epilepsy pre-injury
- •Receiving antiepileptic treatment for documented active seizures in the past 6 months
- •Taking medications that lower seizure threshold including antipsychotics, trazodone and tramadol
- •History of surgery on blood vessels in brain and/or valves of the heart
- •History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders
- •History or current diagnosis of psychotic spectrum disorders (i.e. bipolar, schizophrenia)
- •Significant heart disease as determined by physician review of medical chart
- •Pregnant at time of enrollment or any time during study participation
Outcomes
Primary Outcomes
Change in the Mayo Portland Adaptability Inventory (MPAI)
Time Frame: baseline, 5 weeks, 10 weeks, 20 weeks
Self-reported ability, adjustment and community participation. It is comprised of 30 items and three subscales: Ability Index, Adjustment Index and Participation Index. Items are scored on a 5-point Likert scale, with lower scores indicating higher levels of functioning.
Secondary Outcomes
- change in the PTSD Checklist (PCL)(baseline, 5 weeks, 10 weeks, 20 weeks)